Many thanks to all who sent such kind comments on my FDA Part 15 testimony today. My complete remarks can be found here.
A few tidbits:
As Walter O’Malley – the man who moved the Brooklyn Dodgers to Los Angeles once commented, “The future is just one damn thing after another.”
The Internet can be extremely useful in informing patient discussions with doctors. It can be a helpful tool to empower an individual in their medical decisions. But it is important to remember that not everything online is true. The Internet has made it easier than ever before for charlatans and quacks to spread fear and misinformation. Mark Twain wrote, “Beware of health books. You might die of a misprint.” Having a website does not replace having insight.
Regulated companies mustn’t feel safe behind a social media Maginot Line. Social media is a social movement and using the excuse that healthcare firms can’t engage because “we’re different,” misses the point. Compliance issues are very important, but it’s precisely because of the “special difference” -- the responsibility of advancing the public health -- that these companies must engage actively and creatively in social media.
As the great social media philosopher, Buffalo Springfield, opined, “There’s something happening here. And what it is ain’t exactly clear.”
One thing that healthcare companies’ worry about is that social media commentators will not factually report the news. A legitimate concern, but is this any different then accurately pitching a story to a reporter at the New York Times and having her miss or misrepresent a clinical data point?
Whether it’s the New York Times or a blog or a social media site for caregivers, information “in” is vetted and controlled. Information “out” is not. Errors and hyperbole are, for better or worse, freedoms of the press.
According to the Pew Internet and American Life Project, 113 million Americans search online for answers to their health questions. Three quarters of these individuals rarely, if ever, check the sources of the material they find
Without the participation of regulated healthcare players, the social media field is left to snake-oil salesmen, Internet drug dealers, unscrupulous trial lawyers and others who operate without almost any constraints whatsoever. Nature abhors a vacuum. It is irresponsible not to correct healthcare information errors. And yet that is precisely the advice being regularly given by regulatory consultants. It is a sad state of affairs indeed that ambiguity on behalf of the FDA has led us to this dangerous state of affairs.
Should companies actively avoid participation – even to the degree of monitoring – lest they uncover an adverse experience? Shouldn’t companies embrace social media so that adverse experiences can be found with greater alacrity? Shouldn’t companies be rewarded for such behavior? If regulated industry wants the FDA to be both regulator and colleague, then it’s not a leap of faith to imagine that the FDA would like industry to be proactive in its search for new ways to surface adverse events.
I know of one large pharmaceutical company whose policy is not to monitor social media sites because they don’t want to unearth adverse events. Is this responsible? Is it even supportable? If this company received a call from a reporter and was asked if they purposely avoid social media so as not to find adverse experiences, would the truth set them free? Legally they may be in compliance, but it wouldn’t look good on Page One or sound very good in front of a congressional subcommittee. “In compliance” and “in the best interest of the public health” must not be mutually exclusive propositions.
As F. Scott Fitzgerald wrote, “At 18 our convictions are hills from which we look; at 45 they are caves in which we hide.”
Social media is still too young an adventure for us to seek shelter in the caves of caution, complacency and compliance.
A few tidbits:
As Walter O’Malley – the man who moved the Brooklyn Dodgers to Los Angeles once commented, “The future is just one damn thing after another.”
The Internet can be extremely useful in informing patient discussions with doctors. It can be a helpful tool to empower an individual in their medical decisions. But it is important to remember that not everything online is true. The Internet has made it easier than ever before for charlatans and quacks to spread fear and misinformation. Mark Twain wrote, “Beware of health books. You might die of a misprint.” Having a website does not replace having insight.
Regulated companies mustn’t feel safe behind a social media Maginot Line. Social media is a social movement and using the excuse that healthcare firms can’t engage because “we’re different,” misses the point. Compliance issues are very important, but it’s precisely because of the “special difference” -- the responsibility of advancing the public health -- that these companies must engage actively and creatively in social media.
As the great social media philosopher, Buffalo Springfield, opined, “There’s something happening here. And what it is ain’t exactly clear.”
One thing that healthcare companies’ worry about is that social media commentators will not factually report the news. A legitimate concern, but is this any different then accurately pitching a story to a reporter at the New York Times and having her miss or misrepresent a clinical data point?
Whether it’s the New York Times or a blog or a social media site for caregivers, information “in” is vetted and controlled. Information “out” is not. Errors and hyperbole are, for better or worse, freedoms of the press.
According to the Pew Internet and American Life Project, 113 million Americans search online for answers to their health questions. Three quarters of these individuals rarely, if ever, check the sources of the material they find
Without the participation of regulated healthcare players, the social media field is left to snake-oil salesmen, Internet drug dealers, unscrupulous trial lawyers and others who operate without almost any constraints whatsoever. Nature abhors a vacuum. It is irresponsible not to correct healthcare information errors. And yet that is precisely the advice being regularly given by regulatory consultants. It is a sad state of affairs indeed that ambiguity on behalf of the FDA has led us to this dangerous state of affairs.
Should companies actively avoid participation – even to the degree of monitoring – lest they uncover an adverse experience? Shouldn’t companies embrace social media so that adverse experiences can be found with greater alacrity? Shouldn’t companies be rewarded for such behavior? If regulated industry wants the FDA to be both regulator and colleague, then it’s not a leap of faith to imagine that the FDA would like industry to be proactive in its search for new ways to surface adverse events.
I know of one large pharmaceutical company whose policy is not to monitor social media sites because they don’t want to unearth adverse events. Is this responsible? Is it even supportable? If this company received a call from a reporter and was asked if they purposely avoid social media so as not to find adverse experiences, would the truth set them free? Legally they may be in compliance, but it wouldn’t look good on Page One or sound very good in front of a congressional subcommittee. “In compliance” and “in the best interest of the public health” must not be mutually exclusive propositions.
As F. Scott Fitzgerald wrote, “At 18 our convictions are hills from which we look; at 45 they are caves in which we hide.”
Social media is still too young an adventure for us to seek shelter in the caves of caution, complacency and compliance.
